Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201701001965195 Date of Approval: 07/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Adductor canal block: effect of volume of injectate on sciatic extension
Official scientific title Adductor canal block: effect of volume of injectate on sciatic extension
Brief summary describing the background and objectives of the trial Recent data suggest that adductor canal block may result in sciatic nerve blockade by diffusion of the injectate to the popliteal fossa. Our hypothesis is that an increase in the volume of the injectate in the adductor canal may result in an increase in the diffusion to the sciatic nerve. This would improve the analgesic effect of the adductor canal block.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied post operative pain
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2017
Actual trial start date 01/02/2017
Anticipated date of last follow up 01/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group normal volume adductor canal block 20 ml ropivacaine 0,375% single injection ultrasoung guided adductor canal block, in the mid-thigh, using the in-plane technique and hydrolocalization 20
Experimental Group High volume adductor canal block 40 ml ropivacaine 0,375% Single injection ultrasoung guided adductor canal block, in the mid-thigh, using the in-plane technique and hydrolocalization 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for an arthroscopic surgery of the knee general anesthesia nerve block refusal consent refusal 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/01/2017 CE-IMKO
Ethics Committee Address
Street address City Postal code Country
Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of clinical sciatic extension 30 mn after the injection 60 mn after the injection
Secondary Outcome Morphine consumption Hour 24 after the injection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut Mohamed Kassab d'Orthopédie Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministère de la santé Bab Saadoun Tunis 1006 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institut Mohamed Kassab d'Orthopédie Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Abderrahmen Bargaoui Institut Mohamed Kassab d'Orthopédie, Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia
Olfa Kabachi Institut Mohamed Kassab d'Orthopédie, Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia
Khaireddine Raddaoui Institut Mohamed Kassab d'Orthopédie, Avenue Habib Bourguiba Ksar Said, La Manouba 2010 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olfa Kaabachi olfa.kaabachi@gnet.tn 0021698317381 Institut Mohamed Kassab d'Orthopédie
City Postal code Country Position/Affiliation
Ksar Said, La Manouba 2010 Tunisia Department of Anesthesia and Intensive care
Role Name Email Phone Street address
Public Enquiries Olfa Kaabachi olfa.kaabachi@gnet.tn 0021698317381 Institut Mohamed Kassab d'Orthopédie
City Postal code Country Position/Affiliation
Ksar Said, La Manouba 2010 Tunisia Department of Anesthesia and Intensive care
Role Name Email Phone Street address
Scientific Enquiries Abderrahmen Bargaoui bargaoui.abd@gmail.com 0021622849078 Institut Mohamed Kassab d'Orthopédie
City Postal code Country Position/Affiliation
Ksar Said, La Manouba 2010 Tunisia Department of Anesthesia and Intensive care
REPORTING
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Changes to trial information